You've spent years getting the science right. You have months to get the compliance infrastructure right. That's the timeline most pre-commercial companies face when the PDUFA date is set and the launch plan accelerates.
There's a checklist, and it's longer than most founders expect. Here's what regulators and partners will look for:
A written compliance program with a code of conduct, policies, and SOPs that reflect your actual commercial activities, not a template from a company twice your size.
A designated compliance officer, whether full-time or fractional, who has authority and access to the board. OIG guidance is explicit on this point.
Training completed before your team starts calling on HCPs. Anti-Kickback, FCA, your own policies, state-specific rules for the jurisdictions where you'll operate.
Fair market value rates established and documented for any HCP engagement types you'll run in your first year. Advisory boards, consulting, and speaker programs all need FMV before the first invitation goes out.
Aggregate spend tracking operational before the first dollar is paid to an HCP. Retro-building this after six months of commercial activity is painful and unreliable.
A PRC/MLR process in place before the first promotional material is produced. Your commercial team will want to move fast. The review process needs to be ready before they are.
HCP engagement policies and approval workflows that route through compliance before commitments are made. The first advisory board cannot be planned in email and approved by the commercial lead. That's how patterns start.
Twelve months before launch is ideal. Six months is workable if you're focused. Three months is triage.
We typically start with a risk assessment scoped to your therapeutic area, commercial model, and target states. That drives the priority order for everything else. Not every company needs every element at launch. But every company needs the core program, the HCP engagement framework, and the reporting infrastructure.
Companies that wait until three months before launch and try to build everything at once. The program exists on paper but nobody's been trained and nobody's using it.
Companies that build the compliance program but forget about state-level requirements. Federal compliance is table stakes. State requirements are where the traps are.
Companies that hire a compliance officer at launch but don't give them the infrastructure. A CCO without policies, processes, and systems is just a title.
Companies that treat the compliance program as a one-time project instead of an ongoing function. The program you launch with is the starting version. It needs to evolve with your commercial operations.
We can build the entire pre-launch compliance infrastructure, serve as fractional CCO through launch and beyond, or supplement your internal team on specific workstreams. The scope depends on what you have and what you need.
Most pre-launch engagements start at 20 to 30 hours per month and scale down after the program is operational.
If your PDUFA date is set and you're thinking about compliance readiness, or if you've already launched and realize you have gaps, we should talk. We'll give you an honest assessment of where you stand and what the priority build looks like.
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